FDA Device

SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler

Hazard

A problem in the software has the potential to be associated with the incorrect reporting of sample results.

What You Should Do

Remedy

On 7/22/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the corrective action.

Products

SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
Brand
Cepheid
UPC
All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a